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Cranial Electrical Stimulation (CES)

Cranial Electrical Stimulation (CES). Cynthia T. Gragnani, Ph.D Walter Reed Army Medical Center October 25, 2010 . Electricity In Medicine. 1868 Judah Moses- “Galvanic Spectacles” 1910 Emil Du Bois-Reymond- “Electrotonus”

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Cranial Electrical Stimulation (CES)

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  1. Cranial Electrical Stimulation (CES) Cynthia T. Gragnani, Ph.D Walter Reed Army Medical Center October 25, 2010

  2. Electricity In Medicine • 1868 Judah Moses- “Galvanic Spectacles” • 1910 Emil Du Bois-Reymond- “Electrotonus” • Present Day-Cardiac Pacemakers, Velocity Tests, Electrotherapy Devices

  3. What is Cranial Electrical Stimulation • Cranial Electrical Stimulation (CES) was established in 1981 as a Class II, Type B medical device regulated and approved by the Food and Drug Administration • CES using mild micro current levels of electrical stimulation applied across the head via transcutaneous electrodes applied to the earlobes • CES can be used to treat a variety of symptoms including; anxiety and insomnia

  4. How does Alpha-Stim Work Legend:Blue arrows:inhibitory interactionsPurple arrows:excitatory interactionsYellow X:suppressed pathways/interactions • Reference:Kirsch, Daniel L. Cranial electrotherapy stimulation for the treatment of anxiety, depression, insomnia and other conditions. Insert: Giordano, James. Illustrating how CES works. Natural Medicine, 23:118-120, 2006.

  5. Method of Use Wet the clips with the conductive solution, and attach them to your earlobes Press the left-hand button to switch on, and press the right-hand button to select 20 or 60 minutes Adjust the intensity of the stimulation using the dial on the side • Image Courtesy of:Electromedical Products International, Inc. (http://www.alpha-stim.com/SCS.html)

  6. Treatment Protocol CES 20 minutes to an hour daily for 1-2 weeks Followed by a reduced schedule of 2-3 CES treatments a week until the symptoms are resolved Use on a as needed basis thereafter

  7. Side Effects & Contraindications Side Effects: • Dizziness (6 cases or 0.13%), headaches (9 cases or 0.20%) and skin irritation (5 cases or 0.11%) seen in approximately 4,541 patients using CES Contraindications: • Pregnancy • Cardiac pacemakers (particularly demand type pacemakers) • Vertigo • Caution with those taking high blood pressure medication • Operating potentially dangerous machinery/vehicles • Use immediately prior to going to sleep

  8. The Scientific Research • Most researched medical device in its class • Over 125 research studies in humans and 29 experimental animal studies • No significant lasting side effects have been reported in over two decades of use

  9. The Scientific Research (cont.) Reference:CES In The Treatment of Insomnia: A review and Meta-Analysis, by Dr. Daniel L. Kirsch & Marshall F. Gilula. Practical Pain Management, 2007.

  10. The Scientific Research (cont.) Reference:Incorporating Complementary and Alternative Medicine Therapies to Expand Psychological Services to Veterans Suffering From Chronic Pain, by Gabriel Tan et al., Psychological Services, 2010.

  11. Current Study at Walter Reed Army Medical Center • Efficacy of Cranial Electrical Stimulation for the treatment of insomnia • Active duty military service members at Walter Reed Army Medical Center • Screening measures: Pittsburgh Insomnia Rating Scale and the Zung Depression Scale • Recruiting 40 subjects • Double-blind, random assignment (functional or nonfunctional condition) • 5 consecutive days of tx • Pre, Mid, & Post Assessment Measures

  12. Outcome Variables Primary Outcome Variables: • Time to sleep, total sleep time, and number of awakenings Secondary Outcome Variables: • Pittsburgh Insomnia Rating Scale-20 • Pre-Sleep Arousal Scale • Epworth Sleepiness Scale

  13. Assessment Measure Schedule

  14. Preliminary Findings • Data collection began in March 2010 • Preliminary Descriptive Data: • Data collected on 18 subjects • 13 Males and 5 females • The majority of the subjects were in the 21-25 age range (e.g. 33%) • Most popular method of treating sleep aliments: Medication (e.g. 50%) • Average initial PIRS score: between 21-39 (e.g. 79%) Scores can range from 0-60. A score of 21 & above indicates a primary diagnosis of insomnia

  15. Clinical Use of CES • Introduction • Training • Acceptance • Recruitment • Pros • Clinical Findings

  16. Insomnia: CES Research References • Kirsch, Daniel L. and Gilula, Marshall. CES in the treatment of insomnia: A review and meta-analysis. Practical Pain Management, 7(7):28-39, 2007 . • Kirsch, Daniel L. Cranial electrotherapy stimulation for the treatment of anxiety, depression, insomnia and other conditions. Insert: Giordano, James. Illustrating how CES works. Natural Medicine, 23:118-120, 2006. • Gilula, Marshall F. and Barach, Paul R. Cranial electrotherapy stimulation: a safe neuromedical treatment for anxiety, depression, or insomnia Southern Medical Journal. 97(12):1269-1270, 2004. • Kirsch, Daniel, L. and Smith R.Cranial electrotherapy stimulation for anxiety, depression, insomnia cognitive dysfunction, and pain. In Bioelectromagnetic Medicine. Paul J. Rosch, Ed. Marcel Dekker, New York, Pp 727-740, 2004. • Kennerly, Richard. QEEG analysis of cranial electrotherapy: a pilot study. Journal of Neurotherapy (8)2, 2004. Presented at the International Society for Neuronal Regulation annual conference, September 18-21, 2003 in Houston, Texas. • Kirsch, Daniel L. Postmarketing survey of Alpha-Stim CES patients. Summarized here and presented in detail in the book The Science Behind Cranial Electrotherapy Stimulation, 2nd Ed., Medical Scope Publishing Corporation, Edmonton, Alberta, Canada, 2002. • Schroeder, M.J., and Barr, R.E. Quantitative analysis of electroencephalogram during cranial electrotherapy stimulation. Clinical Neurophysiology. 112:2075-2083, 2001. Doctoral dissertation, The Graduate School of the University of Texas at Austin, 191 pages, 1999

  17. Anxiety: CES Research References • Annibali, Joseph. Case of the Week: Jeff -- Bipolar Disorder and More. Published online at http:// www.amenclinica.com/blog/tag/alpha-stim-100, April 22, 2010. • Bystritsky, Alexander, Moody, Teena, Hembacher, Emily, Hoffman, Jordan, Moller, Hayley, Feusner, Jamie. Effects of cranial electrotherapy stimulation on brain activity in the resting state. Poster presented at the American Society of Neuropsychopharmacology (ACNP), Hollywood, Florida, December 8, 2009. • Kim, Hyun Jung, Kim, Woon Young, Lee, Yoon Sook, Chang, Moon Seok, Kim, Jae Hwan, and Park, Young Cheol. The effect of cranial electrotherapy stimulation on preoperative anxiety and hemodynamic responses. Korean Journal of Anesthesiology, 55(6): 657- 661, 2008. • Bystritsky, Alexander, Kerwin, Lauren and Feusner, Jamie. A pilot study of cranial electrotherapy stimulation for generalized anxiety disorder, Journal of Clinical Psychiatry, 69:412-417, 2008. • Kirsch, Daniel L. and Gilula, Marshall. Cranial electrotherapy stimulation in the treatment of anxiety disorders: statistical considerations – Part 2. Practical Pain Management, 7(3):22-39, 2007. • Kirsch, Daniel L. and Gilula, Marshall. A review and meta-analysis of cranial electrotherapy stimulation in the treatment of anxiety disorders – Part 1. Practical Pain Management, 7(2):40-47, 2007.

  18. Thoughts/Questions • Contract Information: • Cynthia Gragnani, Ph.D. • Walter Reed Army Medical Center • Phone: 202-782-8820 • Email: Cynthia.Gragnani@amedd.army.mil

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